R2 Pharma Solutions Pty Ltd
Regulatory Affairs Specialist (Remote)
Regulatory Affairs Specialist | R2 Pharma Solutions Pty Ltd |Worldwide
As a Regulatory Affairs Consultant, you will play a crucial role inregulatory compliance projects ranging from pharmaceutical, cosmetic,medical device and food. Including preparing and submitting eCTD dossiersfor the Australia and European market. Your expertise will help us navigatethe regulatory landscape, ensuring timely approval and market access forour client.
...Regulatory Affairs Specialist | R2 Pharma Solutions Pty Ltd | Worldwide
As a Regulatory Affairs Consultant, you will play a crucial role in regulatory compliance projects ranging from pharmaceutical, cosmetic, medical device and food. Including preparing and submitting eCTD dossiers for the Australia and European market. Your expertise will help us navigate the regulatory landscape, ensuring timely approval and market access for our client.
Roles and Responsibilities
- Prepare and compile eCTD submissions in accordance with EU regulations and Australian regulations.
- Coordinate and manage the submission process, ensuring compliance with regulatory requirements.
- Collaborate with cross-functional teams to gather necessary documentation and data.
- Review and assess regulatory changes and their impact on product submissions.
- Maintain up-to-date knowledge of Australian (TGA) and EU regulatory guidelines and best practices.
- Liaise with regulatory agencies as needed to facilitate communication and submissions.
- Provide strategic advice on regulatory pathways and product development.
Prepare dossiers, variations, renewals, and other regulatory documents for submissions to Health Authorities. - Ensure compliance with applicable regulations and guidelines throughout product lifecycle management.
- Manage timelines for submission preparation and follow-up on submissions with health authorities.
- Maintain accurate records of all interactions with Health Authorities.
- Registration of Medical devices within Australia and if necessary in other markets like EU and FDA. Training provided
- Assist with writing and managing regulatory submissions to relevant regulatory authorities, mainly TGA.
- Assist with the preparation and maintenance of Technical product files.
- Assist with other regulatory needs as required in the space of cosmetics, pharmaceuticals, food, veterinary products etc.
Desired Candidate Profile
- Ideally a Tertiary degree in a pharmaceutical discipline.
- At least 5 years experience in regulatory affairs, preferably gained in the pharmaceutical filed.
- Regulatory knowledge of complex eCTD preparation from raw data.
- Experience working with various eCTD tools and software.
- Ability to work on your own initiative, reach decisions and work under pressure.
- Excellent written and spoken English is must.
- Regulatory knowledge of cosmetic products, pharmaceutical products and veterinary products is preferred but not essential (training will be provided).
- Regulatory knowledge within Australia preferred.
- Attention to detail.
Working Conditions
- This is remote working position. Candidates will be required to work from their own workspace or home.
- Candidates will be required to use their own computer and workstation (not provided by the company).
- Suitable workplace setting should be available at home.
- Must be available to start immediately
